Effect of Health Diary on Self-management in Adolescent Patients With Fixed Orthodontic Appliance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorWei XIA, PhD
About this trial
This study aims to use two-arm randomized clinical trials to evaluate the effectiveness of the health diary in helping adolescents wearing fixed orthodontic appliances improve their oral hygiene status, self-management skills, oral health-related quality of life, self-efficacy, intention，number of breakages, and on-time and return visit status.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with malocclusion eligible for fixed appliance orthodontic treatment;
The age of patients ranged from 12 to 18 years;
The patients received orthodontic treatment for the first time;
The patient was alert and had no cognitive or psychiatric impairment;
Disqualifiers
The patient's disease was diagnosed as jaw deformity associated with other diseases. Malocclusion secondary to trauma, tumor, cleft lip and palate;
Patients treated with orthodontic-orthognathic surgery;
The patient currently participating in other oral related intervention studies.
Trial design
Design model
Parallel
Treatments tested in this trial
Health Diary Program
BehavioralThe health diary is constructed based on the theory of health action process approach, which is used to plan and clock for self-management behaviors of adolescent patients during fixed orthodontic treatment.
Traditional Health Education
BehavioralTraditional health education is that the nurse orally teaches the patient about fixed orthodontic knowledge, and the patient obtains a paper information.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Control GroupPlacebo comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Plaque Index
Ramfjord index teeth (16, 21, 24/25, 36, 41, 44/45) were selected. After staining with plaque stain, the plaque area of mesial, middle buccal, distal buccal and lingual surface of each tooth was examined, and the average value of the four dental surfaces was recorded. Finally, the PLI score was calculated by adding the index teeth and dividing by the number of teeth examined.
Time frame
Change from baseline plaque index at 24-weeks follow-up.2
Bleeding Index
It is a combination of visual examination and probing. The probe was inserted into the gingival sulcus for 1 second and then removed. After 30 seconds, the gingival bleeding and the degree of bleeding were observed. Ramfjord index teeth were selected, namely 16, 21, 24/25, 41, 44/45.The detection sites of each index tooth included 6 sites in the mesial, distal and central of the buccal and lingual surface. The sum of the scores of the examined teeth and then divided by the number of examined teeth were used to determine the SBI score of the patient.
Time frame
Change from baseline plaque index at 24-weeks follow-up.Secondary outcomes
1
Self-Management Ability
The self-management Ability scale for Adolescent Patients with fixed orthodontics was used for evaluation. The higher the score of the scale, the higher the self-management ability.
Time frame
Change from baseline plaque index at 24-weeks follow-up.2
Self Efficacy
Self-efficacy in this study refers to oral health care self-efficacy, as assessed by the Oral Health Care Self-efficacy Scale (SEOH-C), with higher scale scores indicating greater self-efficacy.
Time frame
Change from baseline plaque index at 24-weeks follow-up.3
Oral Health Related Quality of Life
OHRQoL was assessed using the Oral Health Impact Profile 14 (OHIP-14), with higher score indicating lower oral health-related quality of life.
Time frame
Change from baseline plaque index at 24-weeks follow-up.4
The number of appliance damage in each follow-up period
The compliance of diet management was indirectly evaluated by monitoring the number of appliance damage. The number of appliance damage between the date of the current visit and the expected date of the next visit was recorded as follows: number of appliance damage = number of brackets lost + number of buccal canals lost + number of archwires broken + number of archwires slipped out of the bracket.
Time frame
The number of appliance damage in each follow-up period change over 24 weeks during intervention from baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wei XIA, PhD
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov